BAHA CORDELLE II


Device Classification Name

hearing aid, bone conduction, implanted

510(k) Number K080363
Device Name BAHA CORDELLE II
Applicant
COCHLEAR BONE ANCHORED SYSTEMS AB
400 inverness parkway
suite 400
englewood, 
CO 
80112

Applicant Contact sean bundy
Correspondent
COCHLEAR BONE ANCHORED SYSTEMS AB
400 inverness parkway
suite 400
englewood, 
CO 
80112

Correspodent Contact sean bundy
Regulation Number 874.3300
Classification Product Code
MAH  
Date Received 02/11/2008
Decision Date 04/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No